Comparison of Papillary Balloon Dilatation Vs.Sphincterotomy for Lithotripsy in Difficult Sphincterotomy or Distal CBD Tapering

NCT00329888 — Unknown, National Taiwan University Hospital

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Comparison of Endoscopic Papillary Balloon Dilatation and Sphincterotomy for CBD Stones With Difficult Sphincterotomy or Distal CBD Tapering

Registry	NCT00329888
Status	Unknown
Study type	Observational
Sponsor	National Taiwan University Hospital (Other)
Conditions	Choledocholithiasis
Interventions	Endoscopic papillary balloon dilatation, Endoscopic sphincterotomy (Procedure)
Dates	start 2006-03-01, completion 2006-05-01, first posted 2006-05-25, last updated 2006-05-25
Locations	1 site in Taiwan

-Summary

Compare endoscopic papillary balloon dilatation vs. endoscopic sphincterotomy for bile duct stones in:

* when sphincterotomy is difficult (periampullary diverticulum, prior sphincterotomy or Billroth II anastomosis)
* when there is distal CBD tapering.

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+Detailed description

Endoscopic papillary balloon dilatation is an alternative to endoscopic sphincterotomy for treating bile duct stones:

* easier and as effective. But...
* a higher risk of pancreatitis.

Conditions including periampullary diverticulum, prior EST, Billroth-II anastomosis, or distal CBD tapering pose difficulty in EST and lithotripsy with increased risk of complications.

Whether EPBD or EST is superior in efficacy or safety under such circumstances is not clear.

+Arms and interventions

Endoscopic papillary balloon dilatation (Procedure)
Endoscopic sphincterotomy (Procedure)

+Eligibility

Sex: All, ages: 0 Years to any

Inclusion Criteria:

* Choledocholithiasis with
* Difficult sphincterotomy:periampullary diverticulum, prior sphincterotomy or Billroth II anastomosis
* or distal CBD tapering.

Exclusion Criteria:

* Patients in whom no endoscopic papillary balloon dilatation or endoscopic sphincterotomy was performed for lithotripsy

+Locations (1)

Facility	City	Country	Status
National Taiwan University Hospital	Taipei	Taiwan

+Publications

1. Minami A, Nakatsu T, Uchida N, Hirabayashi S, Fukuma H, Morshed SA, Nishioka M. Papillary dilation vs sphincterotomy in endoscopic removal of bile duct stones. A randomized trial with manometric function. Dig Dis Sci 1995;40:2550-4. 2. Bergman JJ, Rauws EA, Fockens P, van Berkel AM, Bossuyt PM, Tijssen JG, Tytgat GN, Huibregtse K. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bile duct stones. Lancet 1997;349:1124-9. 3.Komatsu Y, Kawabe T, Toda N, Ohashi M, Isayama M, Tateishi K, Sato S, Koike Y, Yamagata M, Tada M, Shiratori Y, Yamada H, Ihori M, Kawase T, Omata M. Endoscopic papillary balloon dilation for the management of common bile duct stones: experience of 226 cases. Endoscopy 1998;30:12-7. 4. Fujita N, Maguchi H, Komatsu Y, Yasuda I, Hasebe O, Igarashi Y, Murakami A, Mukai H, Fujii T, Yamao K, Maeshiro K. Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial. Gastrointest Endosc 2003;57:151-5.

+Investigators

Wei Chih Liao, MD., Principal investigator, National Taiwan University Hospital